Data Presented at American College of Gastroenterology 2005
Annual Scientific Meeting

HONOLULU, November 2 Over-the-counter (OTC) doses of
non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen and
naproxen can increase the risk of the gastrointestinal (GI)
complications, perforations or holes in the stomach lining, ulcers
and GI bleeds -- together referred to as PUBs -- according to a
substantial review of a national electronic database of 3.2 million
patient health records. An analysis of the data shows that patients
taking low-dose aspirin at the same time as ibuprofen or naproxen
have an even greater likelihood for GI events than those who do not
take aspirin. Joseph Biskupiak, Ph.D., the studys lead
author and research associate professor of pharmacotherapy at the
University of Utah College of Pharmacy, presented these data at the
annual scientific meeting of the American College of
Gastroenterology (ACG).

The analysis evaluated the probability for GI complications
among more than 50,000 people by comparing the incidence of PUBs
during the three months after taking ibuprofen or naproxen, even
one time, versus the six and 12 months before taking either of
these non-selective NSAIDs (ns-NSAIDs). The 15-month time frame was
studied to allow for observation of the potential impact of
ns-NSAID use on PUBs. During the three months after taking
ibuprofen, patients were 2.5 times more likely to develop PUBs than
they were during the six months before taking it. Patients who took
naproxen were 2.74 times more likely to develop PUBs than they were
during the six months before taking it.

During the three months after taking either ibuprofen or
naproxen, the probability of developing PUBs rose significantly
when patients also took aspirin: Patients taking both ibuprofen and
aspirin were 3.36 times more likely to develop PUBs versus taking
ibuprofen alone. Patients taking both naproxen and aspirin were
2.07 times more likely to develop PUBs versus taking naproxen
alone.

Almost 60 million adults in the United States take OTC pain
relievers every day or several days per week. The U.S. Food and
Drug Administration (FDA) requested that the manufacturers of OTC
NSAIDs advise people to take the drugs as directed in the label.
Many labels specify that the drugs should not be taken for more
than 10 days without talking to a healthcare provider.

It is very important that patients discuss their use of
over-the-counter pain medications with their physicians, especially
if used over a prolonged period of time, noted Dr. Biskupiak. There
are significant GI risks associated with use of OTC ibuprofen or
naproxen that people may not be aware of.

It was estimated that stomach complications from using OTC and
prescription ns-NSAIDs have sent more than 100,000 people to the
hospital each year. And over 16,000 people have died. At a
conservatively estimated cost of $15,000 to $20,000 per
hospitalization, the annual costs exceed $2 billion.

The FDA has advised that all NSAIDs, including OTC and
prescription drugs, should have stronger warnings to alert people
to the potential risks of heart, stomach and skin problems.

About The Study The new retrospective review of a U.S.-based
electronic database of 3.2 million outpatient medical records was
designed to assess the risk for PUBs using OTC naproxen 220 mg or
ibuprofen 200 mg. A set of 11,957 subjects on naproxen and 38,507
subjects on ibuprofen met these criteria. Patients were excluded if
they had taken oral steroids or coumadin, or if they had any of the
following conditions that might have influenced the development of
PUBs: infectious diseases, GI cancers, enteritis, colitis, or
diverticula of the intestines. The first time a patient took either
ibuprofen or naproxen was considered the index date from which to
compare the incidence of PUBs before and after. Using these data,
researchers were able to determine whether the odds for developing
a PUB were increased by ibuprofen or naproxen use.

Support for this study was provided by Pfizer Inc.

The University of Utah is internationally regarded for its
research and clinical expertise in the health sciences. Through its
four major health sciences collegesthe University of Utah School of
Medicine; College of Pharmacy; College of Nursing; and College of
Healththe University of Utah is the premier primary-care provider
in the Intermountain West and also trains most of the state of
Utahs physicians, pharmacists, nurses, therapists, and other
health-care professionals.